Relationship Between Oral DMT Burden and Adherence in MS
- Conditions
- Multiple SclerosisAdherence, Medication
- Interventions
- Registration Number
- NCT04676204
- Lead Sponsor
- Monash University
- Brief Summary
STATURE is a prospective observational six-arm translation multi-site study that will run for approx. 4.5 years. The primary aim is to measure treatment burden and its relationship to medication adherence across six self-administered oral disease-modifying therapies (cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, and diroximel fumarate) in multiple sclerosis (MS). The information gained will assist prescribing decision-making; accounting for medication burden at a patient level and potential implications on medication adherence and persistence, thus minimising primary and secondary healthcare costs. Three-hundred and twenty-three individuals with MS will be recruited into the study. Patient-reported outcome measures will be administered via Qualtrics, a secure online data collection tool. Medicare and pharmaceutical benefits scheme (PBS) data will also be collected.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 323
- 18 years or older.
- A confirmed diagnosis of multiple sclerosis.
- Commencement (switching or newly prescribed) of one of the 6 following DMTs within the previous 2-months: cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, diroximel fumarate.
- Able to read and write in English.
- Access to an internet connection and computer facilities, required to complete assessments.
- Use of any other DMT than cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, diroximel fumarate.
- Comorbid neurological condition.
- Severe cognitive or psychological dysfunction deemed to interfere with the person's ability to undertake study requirements, as determined by their MS clinic treatment team (neurologist; MS nurse).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cladribine Cladribine Participants with MS commencing cladribine disease modifying treatment as clinically prescribed. Fingolimod Fingolimod Participants with MS commencing fingolimod disease modifying treatment as clinically prescribed. Ozanimod Ozanimod Participants with MS commencing Ozanimod disease modifying treatment as clinically prescribed. Dimethyl Fumarate Dimethyl fumarate Participants with MS commencing dimethyl fumarate disease modifying treatment as clinically prescribed. Teriflunomide Teriflunomide Participants with MS commencing teriflunomide disease modifying treatment as clinically prescribed. Diroximel Fumarate Diroximel fumarate Participants with MS commencing diroximel fumarate disease modifying treatment as clinically prescribed.
- Primary Outcome Measures
Name Time Method Medication Burden 24-months Identification of medication burden will be calculated into indices of pre-workup and monitoring time, refill and administration and side-effects. This will allow the development of an indices of overall perceived burden, as well as sub-indices of specific perceived burden.
Medication Adherence (MPR) 24-months Identification of medication adherence, persistence and switching between oral DMTs will be calculated as the medication possession ratio (MPR) collected from pharmaceutical benefit scheme claims over the 24-month enrollment period. In addition, basic self-reported adherence and discontinuation will be collected.
Medication Adherence (PDC) 24-months Identification of medication adherence, persistence and switching between oral DMTs will be calculated as the proportion of days covered (PDC) collected from pharmaceutical benefit scheme claims over the 24-month enrollment period. In addition, basic self-reported adherence and discontinuation will be collected.
- Secondary Outcome Measures
Name Time Method Multiple Sclerosis Quality of Life-54 (MSQOL-54) 24-Months The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is a structured, self-report questionnaire examining quality of life that contains 54-items, generating 12 subscales with two summary scores (physical health and mental health) and two additional single-item measures (satisfaction with sexual function and change in health). In scoring the MSQOL-54, two summary scores (physical and mental health) are produced from a weighted combination of scale scores, where scale scores range from 0 to 100, with higher scale score indicating improved quality of life. Quality of life (QoL) is being utilised as an outcome measure to identify whether QoL is predicted by 24-month MPR/PDC adherence and persistence.
Trial Locations
- Locations (1)
Monash University
🇦🇺Melbourne, Victoria, Australia